Approval Order StatementApproval for a valved graft version of the carbomedics(r) prosthetic heart valve (cphv). The device, as modified, will be marketed under the trade name carbomedics(r) carbo-seal(tm) ascending aortic prosthesis (aap) and is indicated for use in open heart surgery for simultaneous replacement of the ascending aorta and the aortic valve in cases of aneurysm, dissection, or other disease conditions of hte aorta combined with disease or degeneration of the aortic valve. The device is available in the sizes of 21, 23, 25, 27, 29, 31, and 33 mm.